Prozac Birth Defects

Prozac, an SSRI (selective serotonin reuptake inhibitor) medication, is prescribed for depression, bulimia, anxiety issues, obsessive-compulsive disorder, and more. Although the drug has been beneficial for many, the side effects can outweigh the benefits, especially for pregnant women, who run the risk not only of maternal health issues, but infant birth defects as well.

Depression and Prozac

Over 30 million persons in the United States have been prescribed antidepressants. A significant number of patients include women, often mothers or pregnant women, who suffer from clinical depression. Expectant mothers are often forced to decide what is best for them and their unborn baby. The choices are stark. Should the mother stay on the antidepressant throughout the pregnancy and increase the chances of birth defects? Or should she stop taking the medication and run the risk of having a more severe case of depression or even develop suicidal tendencies?

If a pregnant mother decides to stop using Prozac, the benefits and risks must be weighed carefully. It’s recommended that women discuss their option with a physician in order to make an informed decision. If a pregnant woman stops using Prozac, she’s at risk for an increased chance of miscarriage. In addition, if the depression is severe, there is a heightened risk of suicidal thoughts. According to  Mark I. Levy, MD, a psychiatrist from the University of California, taking Prozac while pregnant may be more beneficial than stopping: 

“The main benefit is it is preventing depression at a vulnerable time in a vulnerable person. Prozac can be helpful in warding off postnatal depression, which is bad for a woman and bad for her baby,” Dr. Levi said.

Several physicians agree with Dr. Levi, including Lee S. Cohen, MD., of Massachusetts General Hospital and Harvard Medical School. 

“If women stop antidepressant treatment during pregnancy, their risk for recurrence of their underlying depression is very, very high. And depression during pregnancy is associated with bad outcomes for newborns and very bad outcomes for women,” said Dr. Cohen. 

Regardless, each case is unique and if you are currently taking Prozac yet undecided if you stop taking it while pregnant, it’s important to talk to your physician before deciding the best course of action for you.

Prozac and Pregnancy

Fluoxetine is an antidepressant first developed by researchers at Eli Lilly and Company in 1974.  Marketed as Prozac and other names such as Sarafem and Fontex, fluoxetine is a drug in the selective serotonin reuptake inhibitor (SSRI) family  It is the third most-prescribed antidepressant after sertraline and citalopram.

Though Prozac is primarily used to treat depression, it is also used to treat bulimia, obsessive-compulsive disorder, and other conditions. Like other SSRIs, Prozac raises levels of serotonin, a naturally-occurring biochemical that helps a person maintain a sense of well-being and happiness.

When antidepressants have the desired effect, the increased levels of serotonin help to relieve the unhappiness and lack of hope that are characteristic symptoms of major depression. The Food and Drug Administration (FDA) lists most SSRIs, including Prozac, as Class C drugs for pregnant women. Class C drugs have indicated that they have negative side effects on test animals which were given high doses. The effects of Class C medications on human babies cannot be measured directly because it is unethical to use infants as test subjects. However, the adverse effects of Prozac are  inferred by physicians’ observations and the number of associated birth defects.

Health Risks to Babies from Prozac

Prozac, like all Class C SSRI medications, can increase the risk of certain birth defects if a baby is exposed to the antidepressant before birth. Some of the most common defects caused by prenatal exposure include:


According to a study published in the Archives of General Psychiatry, infants who are exposed to Prozac and other SSRI medications have an increased risk of developing autism. In fact, if a pregnant woman takes Prozac during the nine months of pregnancy, the chances of the baby developing autism doubles. Other birth defects may include:

  • Anencephaly (a deadly defect of the neural tube)
  • Craniosynostosis
  • Cleft palate
  • Cleft lip
  • Club Foot
  • Gastroschisis
  • Tetralogy of Fallot

Risks to Pregnant Women Associated with Prozac

Although the side effects of Prozac in pregnant women are less severe than those of other SSRIs, it’s important to note that there are still several risks that may occur when taking Prozac while pregnant, including:

  • Sexual dysfunction
  • Dry mouth
  • Headache
  • Drowsiness
  • Nausea
  • Diarrhea
  • Nervousness
  • Restlessness
  • Agitation
  • Insomnia
  • Increased sweating and
  • Weight gain

Who is Responsible If Prozac Causes Birth Defects?

Medical studies carried out over the past several years have linked the use of SSRI-type antidepressants by pregnant women and an increased risk of birth defects in newborn babies. Doctors have ethical and legal obligations to tell expectant mothers about the adverse effects of taking SSRIs such as Prozac during pregnancy. Most doctors attempt to give themselves legal cover before writing a prescription for fluoxetine by getting patients to sign a document stating that they are not pregnant nor are they planning to have a baby within a certain period of time.

However, there are physicians who fail to tell their pregnant patients about known and possible adverse effects of Prozac. By not informing patients about possible dangers and not advising them about other forms of treatment for depression, those doctors may be liable for damages.

In addition, Eli Lilly, the pharmaceutical company that developed fluoxetine and held the patent until 2001, has faced a plethora of lawsuits since Prozac was introduced in the late 1980s  Most of these suits center on the drug’s failure to relieve the symptoms in depression in some patients. However, Eli Lilly and other manufacturers of Prozac or generic fluoxetine have also been sued as a result of cases where women gave birth to babies who suffered health problems caused by antidepressant use during gestation.